News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

IMPORTANT ALERT for All Clinical Laboratories: New Influenza-Like Disease in Mexico Is Being Watched by Health Agencies Worldwide

Similar cases reported in the California counties of San Diego and Imperial, as well as in San Antonio, Texas

Mexico is dealing with what experts believe to be a new strain of influenza which has a combination of genes not previously identified with either human or swine flu. However, this emerging strain-described as A/H1N1 in news reports-seems to be most similar to a flu virus circulating in pigs since 1999. A troubling number of deaths connected to this virus have caught the attention of Mexican health authorities, along with the World Health Organization (WHO), health officials in Canada, and, as of this afternoon, the Centers for Disease Control and Infection (CDC).

Dark Daily is the first laboratory news resource to alert medical laboratories, pathology laboratories and experts in laboratory medicine to this situation, which has only caught the attention of news outlets in recent hours. In particular, clinical laboratories in states bordering Mexico, including Texas, New Mexico, Arizona, and California, will want to be particularly vigilant.

(more…)

Good News for Labs: HHS Delays Implementation Deadline for ICD-10 to 2013, Version 4010/4010A1

Pathologists and lab directors concerned about training staff to implement the new ICD-10 code sets can relax-but only just a bit! The federal Department of Health & Human Services (DHHS) has pushed back the compliance deadline for implementing the International Classification of Diseases, 10th Revision (ICD-10) code sets. The new implementation deadline of October 1, 2013; replaces the existing deadline of October 1, 2011.

As it announced this extension in implementation of ICD-10 on January 15, HHS also set a date of January 1, 2012, for implementing the so-called X12 standard, Version 5010, for certain electronic health care transactions. Version 5010 is an important prerequisite to adopting ICD-10 and includes updated standards for claims, remittance advice, eligibility inquiries, referral authorization, and other administrative transactions. Version 5010 accommodates the ICD-10 code sets, which are not supported by Version 4010/4010A1, the current X12 standard, HHS said.

These two implementation dates give labs additional time to prepare and train for using the new codes. Labs will find the implementation of ICD-10 to be a costly process, in part because ICD-10 uses 155,000 seven-digit codes, compared with the existing 17,000 codes in ICD0-9. Bloomberg news reported on January 14 that the new codes will be a “nightmare” for healthcare providers.

In a report last year, Nachimson Advisors, LLC, estimated that every provider will incur conversion costs in at least six ways. Organizations representing physicians and laboratories, including the American Medical Association and the American Clinical Laboratory Association (ACLA)  commissioned the report, which projected the ICD-10 implementation costs for small, medium, and large physician groups.

The Nachimson Report calculated that the typical small group of three physicians would incur costs of $83,290 to comply with ICD-10. A typical medium-sized group of 10 physicians would spend $285,195, and a typical large physician practice of 100 providers would spend $2.7 million. (See “ICD-10 Conversion Costs Underestimated by HHS,” The Dark Report, Oct. 20, 2008.) These costs include expenses for:

1) education;

2) process analysis;

3) changes to superbills;

4) information technology;

5) documentation; and,

6) cash flow disruption

Conversion costs will be even higher for labs. That’s because labs must fund extensive changes in their information systems. Labs will also need to train not only staff, but also referring physicians. One large national lab estimated that it will spend $40 million to convert to ICD-10.

Armed with the knowledge about these high costs to implement ICD-10 and train referring physicians on the new codes, physician groups and ACLA have lobbied Congress to order HHS to delay implementation. HHS received more than 3,000 comments on the ICD-10 proposal, said Kerry Weems, acting administrator of the federal Centers for Medicare & Medicaid Services (CMS).

“A number of commenters asked for a delay in the compliance dates for both ICD-10 and Version 5010, citing implementation costs, the need to train health care personnel, and to assure ample time for testing between trading partners,” noted Weems. “HHS recognized these concerns and the final rules delay the implementation dates between the proposed and final rules by 21 months for the 5010 standards, and by 24 months for the ICD-10 codes.”

Medical laboratories and pathology group practices should already have a strategy in lace for handling the transition to ICD-10 codes. This two-year extension may be welcome today, but the United States is a full two decades behind the rest of the world in its use of ICD-10 codes. So further delays in ICD-10 implementation beyond 2013 should not be expected.

Related Articles:

Two Labs in Friendly Race to Win First ISO 15189 Accreditation in U.S.

It’s a sprint to the finish line in the friendly race to be first laboratory in the United States to earn accreditation under ISO 15189:2007 Medical Laboratories. The two contestants are Piedmont Medical Laboratory (PML) of Winchester, Virginia, and Avera Health Laboratories of Sioux Falls, South Dakota.

Within the next six to eight weeks, both laboratories expect to complete all steps in the accreditation process. Each will eagerly await word that, based on the final assessment by outside auditors, all requirements have been meet and ISO 15189:2007 accreditation is granted.

This achievement will be a milestone event for the clinical laboratory industry. It marks the arrival of quality management systems (QMS) in laboratory management. This changes the status quo because quality management systems, like ISO:15189:2007 Medical Laboratories, are a comprehensive approach to managing all activities in the laboratory organization.

Until recently, both laboratories have chosen to keep their pursuit of ISO 15189:2007 accreditation out of the public eye. That is why this important story has gone unnoticed by the greater laboratory public and unreported in The Dark Report. But that is no longer the situation.

At the upcoming Lab Quality Confab on September 24-25 in Atlanta, both Piedmont Medical Laboratory and Avera Health Laboratories will be present and will make presentations on their quality journey. This is the first opportunity for lab directors and pathologists to directly the reasons behind this strategic decision and the lessons learned during the ISO 15189:2007 accreditation process.

To further help lab manager and pathologists understand the ramifications of this milestone, this week’s issue of The Dark Report published interviews with the laboratory leaders of Piedmont Medical Laboratory and Avera Health Laboratories. Among major motivations to spend the money and resources to achieve ISO 15189 accreditation was the competitive advantage each lab would realize, both with providers in the community as well as managed care plans.

In their Dark Report interview, both PML’s CEO, Joseph Skrisson, and Benita Haines, PML’s Quality Management, Compliance and Education Coordinator, stressed that ISO 15189 accreditation was triggering ongoing benefits to the laboratory, both internally in operations, quality and productivity, and externally, with regional payers and the community at large.

Leo Serrano, Director of Laboratory Services for Avera Health Laboratories, similarly stressed how ISO 15189 accreditation would help boost the competitive position of his laboratory in its service region. In fact, because of Avera’s commitment to quality, Avera’s senior administrators were immediately supportive when the ISO 15189 strategy was first proposed.

The arrival of quality management systems, including ISO 15189, will be discussed in several important sessions at Lab Quality Confab in Atlanta at the Hilton Hotel on September 24-25. Laboratory managers, pathologists, and others wanting to understand the ramifications of this new development in laboratory medicine should make plans to attend the second annual L ab Quality Confab on Quality Management in Diagnostic Medicine.

More than 50 sessions and topics will be presented, covering the full range of laboratory and pathology operations, ranging from specimen collection and courier logistics to using Lean with automation in the high-volume core laboratory. Poster sessions will take place, and national awards and prizes totaling $6,000 will be awarded. To see topics, speakers, and all the events at Lab Quality Confab, visit http://www.labqualityconfab.com.

To register for Lab Quality Confab, visit http://www.labqualityconfab.com/register.htm.

Finally, Dark Daily observes that it has taken only five years, since 2003, for the laboratory industry go from the first examples of Lean and Six Sigma in hospital laboratory operations to the first examples of ISO 15189:2007 accreditation by a hospital laboratory and an independent laboratory. These developments demonstrate how the art and science of clinical laboratory management continues to be influenced by the principles of quality management.

Related Information:

Four Easy Ways to Register:
1. Register ONLINE
2. Call 800-560-6363. Our friendly staff can register you quickly and easily, as well as answer any questions you may have.
3. Fax this complete registration form to 512-264-0969
4. Mail the one page form with payment to:

THE DARK REPORT
21806 Briarcliff Dr.
Spicewood, TX 78669

;